Chiropractic Treatment for Headache Among Children Aged 7-14

NCT02684916 | Completed

• 1 other identifier: 1504
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to assess the effectiveness of chiropractic manipulation treatment versus placebo treatment in children suffering from headache for more than six months.

Conditions

Chronic Headache

Keywords

Chiropractic spinal manipulation; Children; Pediatric; Headache

Outcome Measures

Primary Outcomes (1)

• Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months.

  Patient or parent reported via sms-service.

  Assessed weekly for a period of four months.

Secondary Outcomes (3)

• Intensity of headache, graded on a 0-10 scale, where 10 is the worst, over four months analyzed as repeated measures with end-point at four months.

  Assessed weekly for a period of four months.

• Use of medicine the past week due to headache over four months analyzed as repeated measures with end-point at four months.

  Assessed weekly for a period of four months.

• Improvement on a seven point Likert scale (from 'totally recovered' to 'worse than ever') assessed at four months.

  Assessed at the end of four months follow-up.

Study Arms (2)

Chiropractic treatment

EXPERIMENTAL

Visit with active treatment.

Procedure: Chiropractic treatment

Placebo

PLACEBO COMPARATOR

Visit without active treatment.

Procedure: Placebo

Interventions

Chiropractic treatment PROCEDURE

The child receives chiropractic manipulation treatment in the neck and in the spine and pelvis according to individual needs. They also receive a written list of general advice regarding lifestyle and habits. The parents and the child are unaware of group allocation.

Chiropractic treatment

Placebo PROCEDURE

Non-therapeutic placebo treatment: a broad non-specific contact outside the spinal column is taken on subject's scapula and gluteal region lying in a side posture position, on the scapulae in a prone position and on trapezius muscles in a sitting position. In those positions the chiropractor pushes in a non-intentional and non- therapeutic directional line with a low-amplitude, low velocity push maneuver. All contacts are performed without soft tissue pre-tension and gentle contact, to insure that no joint cavitation occurs. To obtain a noise that many people associate with a chiropractic spinal adjustment, a de-activated Activator Instrument is used on the arm of the chiropractor to give a click-sound. General advice on lifestyle and habits is handed out to the placebo group as well.

Placebo

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Headaches for at least half a year.
• Headache for at least 4 days pr. month.
• At least one musculoskeletal dysfunction as identified by an experienced chiropractor as a movement restriction in one or more of the spinal joints and painful on manual palpation suitable for chiropractic manipulation treatment at the time of the initial screening.
• Able to report information on headache via cell phone either by him- or herself or with help from the parents.

You may not qualify if:

• Contraindications for chiropractic treatment
• Acute neck or head trauma during the trial period which is estimated to influence the headache

Sponsors & Collaborators

• Nordic Institute of Chiropractic and Clinical Biomechanics: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Kiropraktisk Center og Børneklinik

Brønderslev, 9700, Denmark

Location

Related Publications (4)

• Lynge S, Vach W, Dissing KB, Hestbaek L. Potential effect modifiers for treatment with chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years: development of and results from a secondary analysis of a randomised clinical trial. Chiropr Man Therap. 2023 Jul 11;31(1):20. doi: 10.1186/s12998-023-00492-2.

  PMID: 37434189 DERIVED

• Dissing KB, Vach W, Lynge S, Christensen HW, Hestbaek L. Description of recurrent headaches in 7-14-year-old children: Baseline data from a randomized clinical trial on effectiveness of chiropractic spinal manipulation in children with recurrent headaches. Chiropr Man Therap. 2023 Jan 30;31(1):5. doi: 10.1186/s12998-023-00479-z.

  PMID: 36717833 DERIVED

• Lynge S, Dissing KB, Vach W, Christensen HW, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years - a randomised clinical trial. Chiropr Man Therap. 2021 Jan 7;29(1):1. doi: 10.1186/s12998-020-00360-3.

  PMID: 33413519 DERIVED

• Lynge S, Hartvigsen J, Christensen HW, Vach W, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7-14 years, Protocol for a randomized clinical trial. Chiropr Man Therap. 2019 Aug 23;27:40. doi: 10.1186/s12998-019-0262-y. eCollection 2019.

  PMID: 31462990 DERIVED

MeSH Terms

Conditions

Headache Disorders; Headache

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susanne L. Rosing, D.C., MSC

  Nordic Institute of Chiropractic and Clinical Biomechanics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 18, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 9, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)